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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K253152
Device Name BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
Applicant
Biozen, LLC
7023 N Classen Blvd.
Oklahoma City,  OK  73116
Applicant Contact Omer Inan
Correspondent
Biozen, LLC
7023 N Classen Blvd.
Oklahoma City,  OK  73116
Correspondent Contact Omer Inan
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/26/2025
Decision Date 05/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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